BEUDAMED
    FDA Adverse Event Death Summary report: N

    NONE

    MDR report key: 2092081 · Received May 18, 2011

    Report

    Report Number
    2182208-2011-00681
    Event Type
    Death
    Date Received
    May 18, 2011
    Date of Event
    November 24, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTD
    PMA / PMN Number
    K911302
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION. (B)(4):THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT OUTER TUBING OVERLAY WITH COSMETIC ENVIRONMENTAL STRESS CRACK AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED TWO DAYS AFTER THE IMPLANT OF THE DEVICE. FURTHER INFORMATION RECEIVED INDICATED THE PATIENT "WENT DOWN" IN THE EVENING, THE DEVICE TRIGGERED LEAD INTEGRITY ALERT APPROXIMATELY FORTY MINUTES LATER, AND THE PATIENT WAS THEN SHOCKED EXTERNALLY, CARDIOPULMONARY RESUSCITATION WAS PERFORMED. THE PATIENT DIED IN THE EMERGENCY ROOM. CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE IMPLANTABLE LEAD ADAPTOR DTD MEDTRONIC, INC. 586638M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death